Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

6.6

Externally provided products and services

6.6.2 a)

Note: In some industries, such as dietary supplement or pharmaceutical, the use of specific reference materials is mandated by the authoritative body, for example, the USP Reference Standards or the EP Certified Reference Standards. Reference Materials/Standards obtained from such authoritative sources are presumed to be suitable for their defined uses.

7

Process requirements

7.1.3 Note: Customer specifications may be an important aspect of the laboratory’s samples, therefore procedures for responding to out of specification results should be considered. The degree to which out of specification results are investigated can vary, so the laboratory is encouraged to design procedures that suit the industries they serve. Guidelines are available from organizations such as FDA and TGA.

7.2

Selection, verification and validation of methods

7.2.1

Selection and verification of methods

7.2.1.1 A laboratory may use an in-house method that has demonstrated superior performance or utilizes more modern technology, and has been adequately validated as defined in this document. However, methods of analysis that are specified in law or regulation shall be followed in accordance with those requirements.

7.2.1.5

Method verification is confirmation that the laboratory has defined and can obtain the required performance for its purpose (e.g. matrix applicability, LOD and precision).

Note: Method verification guidelines are available such as AOAC’s “ How to Meet ISO 17025 Requirements for Method Verification located at AOAC.org, and Eurochem’s “The Fitness for Purpose of Analytical Methods A

Laboratory Guide to Method Validation and Related Topics” located at https://www.eurachem.org/images/stories/Guides/pdf/MV_guide_2nd_ed_EN.pdf

7.2.2

Validation of methods

7.2.2.1

Note: Laboratories undergoing initial accreditation of a method already in use may encounter challenges if the validation was performed using processes not compliant with this standard. It is recommended that laboratories take this into account in their procedure(s).

Note: In addition, the laboratory should have successful proficiency testing results to qualify the method as outlined in section 7.7.2.

Note: For methods in use prior to accreditation, laboratories may be able to support t he fitness of their method performance by compiling historical data, if actual validation data is no longer available that provides objective evidence of accuracy, repeatability or reproducibility, measurement uncertainty of the results, limit of detection and quantification, and linearity. Note: The laboratory should have a policy or procedure that provides guidance on what degree of validation is required for method modifications. Laboratories should confirm whether their accreditation body has policies regarding modifications. Modifications are the differences between the laboratory’s method procedure and the standard method it references, such as: changes in results, changes in stoichiometry, technology, science, a change in

08/09/2018